BridgeMD
New treatment option for Esophageal Squamous Cell Carcinoma
Official title Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT05495152
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Histologically proven squamous cell carcinoma.
- Tumours are located in the thoracic oesophagus.
- Age is between 18 years and 70 years.
- ECOG performance status of 0 or 1.
- Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and...
You likely can't join if
- Patients receive neoadjuvant chemoradiation therapy.
- Patients with pathological complete response (pCR).
- No. of lymph node dissection \< 15.
- Patients with clinical stages T1-2N+M0 and receive upfront surgery.
- Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy.
- Patients requiring systemic steroid medication.
See the full eligibility criteria
- Histologically proven squamous cell carcinoma.
- Tumours are located in the thoracic oesophagus.
- Age is between 18 years and 70 years.
- ECOG performance status of 0 or 1.
- Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologically proven T1-2N+M0 after upfront surgery.
- No metastatic cervical lymph nodes.
- R0 resection is achieved by the minimally invasive esophagectomy (MIE) or open McKeown approach with total two-field lymph nodes dissection or three-field lymph nodes dissection.
- No prior therapy was administered against other cancers.
- Adequate bone marrow function: white blood cell count ≥ 4×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/l; platelets ≥ 100×109/L; haemoglobin ≥ 9 g/dl.
- Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 × ULN (ULN as per institutional standard).
- Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using the Cockcroft-Gault formula.
- Normal thyroid function.
- Written consent is obtained.
- Patients receive neoadjuvant chemoradiation therapy.
- Patients with pathological complete response (pCR).
- No. of lymph node dissection \< 15.
- Patients with clinical stages T1-2N+M0 and receive upfront surgery.
- Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy.
- Patients requiring systemic steroid medication.
- Patients with severe postoperative complications and not suitable for adjuvant therapy.
- Synchronous or metachronous (within 5 years) double cancers.
- Patients ever received immunotherapy.
- Active infection requiring systemic therapy.
- Patients ever received organ transplant or allogenic haemopoietic stem cell transplantation.
- Patients with human immunodeficiency virus (HIV) infection.
- Psychiatric disease.
- Pregnant or lactating women or women of childbearing potential.
- Hypersensitivity for Sintilimab.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.